MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CS-25802-E

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Reaction (2414)

Event Date 10/16/2019

Event Type  Death  

Manufacturer Narrative

(b)(4).Additional information: it is reported that the hospital was not sure if the coating of the catheter caused the allergic reaction or other drugs that were used during the procedure.A patient death occurred.

Event Description

The customer reports the event as: ae symptoms: blood pressure decreased, blood oxygen decreased, airway pressure increased, shock, arrythmia, and red spotted papule on the chest and arms.Ae description: (b)(6) years old man denied any systemic disease.On (b)(6) 2019: admitted for thyroid ca with scheduled total thyroidectomy with modified radical neck dissection.On (b)(6) 2019: in operating room.Vital readings before anesthesia induction: bp 190/105mmhg; hr 81bpm; spo2: 97% at 08:15, iv injection glycopyrrolate 0.2mg / fentanyl 50mcg/2% lidocaine 50mg / 2% propofol 200mg / rocuronium 80mg / methasone 10mg / 1% propofol 50mg, 50mg, 30mg, 50mg, 50mg / succinylcholine 80mg.During this period, the patient was intermittently given labetalol total 10mg to maintain hemodynamically stable due to high bp and hr.After anesthesia induction completed, patient was given sevoflurane to maintain anesthesia depth.At 09:15, inserted and fixed cvc at right femoral vein (catheter coating with chlorhexidine/silver sulfadiazine) at 09:22-09:26, the patient's blood pressure decreased with hypoxemia, airway pressure increased, and red spotted papule were found on the chest and arms.It was suspected of severe anaphylactic shock.The patient was found pea right away.Epinephrine and cpr were given at once.At 09:30, cardiac surgery ecmo team was called to stand by.At 09:40, started ecmo installation.At 09:45-10:10, continuing cpr.Defibrillated 3 times due to vf.At 10:20 ecmo installed and start running.

Event Description

The customer reports the event as: ae symptoms: blood pressure decreased, blood oxygen decreased, airway pressure increased, shock, arrythmia, and red spotted papule on the chest and arms.Ae description: 56 years old man denied any systemic disease.(b)(6) 2019: admitted for thyroid ca with scheduled total thyroidectomy with modified radical neck dissection.(b)(6) 2019: in or.Vital readings before anesthesia induction: bp 190/105mmhg; hr 81bpm; spo2: 97% at 08:15, iv injection glycopyrrolate 0.2mg / fentanyl 50mcg/2% lidocaine 50mg / 2% propofol 200mg / rocuronium 80mg / methasone 10mg / 1% propofol 50mg, 50mg, 30mg, 50mg, 50mg / succinylcholine 80mg.During this period, the patient was intermittently given labetalol total 10mg to maintain hemodynamically stable due to high bp and hr.After anesthesia induction completed, patient was given sevoflurane to maintain anesthesia depth.At 09:15, inserted and fixed cvc at right femoral vein (catheter coating with chlorhexidine/silver sulfadiazine).At 09:22-09:26, the patient's blood pressure decreased with hypoxemia, airway pressure increased, and red spotted papule were found on the chest and arms.It was suspected of severe anaphylactic shock.The patient was found pea right away.Epinephrine and cpr were given at once.At 09:30, cardiac surgery ecmo team was called to stand by.At 09:40, started ecmo installation.At 09:45-10:10, continuing cpr.Defibrillated 3 times due to vf.At 10:20 ecmo installed and start running.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified to suggest a manufacturing related issue.The instructions-for-use contraindicates this device on patients with known hypersensitivity to chlorhexidine acetate, silver sulfadiazine, and/or sulfa drugs.It was not stated whether the patient had any of these sensitivities.Without the device to evaluate and based on the customer report, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 8 FR X 20 CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9576328
• MDR Text Key: 174534873
• Report Number: 3006425876-2020-00040
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2020
• Device Catalogue Number: CS-25802-E
• Device Lot Number: 71F18M1690
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/13/2019
• Initial Date FDA Received: 01/10/2020
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEFIBRILLATORECMO; DEFIBRILLATORECMO; DEFIBRILLATORECMO
• Patient Outcome(s): Death; Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 103